[Hiring] Lead Auditor @G-MED NORTH AMERICA, Inc.

Role Description

GMED North America is hiring a Medical Device QA Auditor with prior industry experience to join our US team. This is a home-based role with travel to client sites.

Utilizing their past experience in engineering, design, or quality control of medical devices, combined with rigorous GMED training, our QA Auditors conduct ISO 13485/MDSAP audits and CE Marking activities for clients to ensure products meet international standards and are go-to-market ready.

The ideal candidate will need hands-on technical experience with medical devices in the following categories:

• Active devices
• Non-active devices
• Plastics
• Metals

Essential Functions:

• Deliver GMED NA’s third-party audit services to assigned clients in accordance with all GMED, scheme and regulatory requirements.
• Analyze quality systems and assess:
• Quality Management Systems according to ISO Standards ISO 9001:2015 and ISO13485:2016
• CE Marking certification under the applicable European Directives & Regulations:
• Medical Devices 93/42/EEC (MDD)
• Active Medical Device Implantable 90/385/EEC (AIMD)
• In Vitro Diagnostics devices 98/79/EC (IVDD)
• EU MDR 2017/745
• EU IVDR 2017/746
• Quality Management Systems under the requirements of the Medical Device Single Audit Program (MDSAP)
• Manage a portfolio of assigned clients based on geographic location and a match of qualifications and client contract requirements.
• Client management includes contacting them to schedule the visit, planning the assessment, making appropriate travel plans, conducting assessments, completing reports, and managing results.
• Participate in professional development and training opportunities to achieve necessary certifications and statuses.

Qualifications

• Bachelor’s degree in computer and software technology, biology, chemistry, biochemistry, electrical/electronic/mechanical or bioengineering, human physiology, medicine, physics, or biophysics.
• A minimum of four years of full-time hands-on (R&D, manufacturing, testing and/or auditing) work experience in the field of medical devices or related sectors.
• At least two years in the area of quality management (experience working in an organization governed by regulations and standards).

Requirements

• Impartiality
• Confidentiality
• Ability to function independently and in a team environment
• Organizational skills & time management
• Attention to details
• Strong oral and written communication skills
• Critical reasoning
• Decision making
• English language skills
• Leadership skills
• Ability to draw up demonstrative records and reports
• Reliability and accountability

Benefits

• Group-sponsored health, dental, and vision coverage
• Flexible spending accounts
• Short-term and long-term disability
• Company-paid life insurance
• Competitive base salary
• Annual bonus based on company performance
• 401K retirement program
• Option to telework
• Flexible working arrangements
• Generous time off program
• Paid holidays
• Paid bereavement leave
• Paid parental leave
• Commuter benefits program for public transportation
• Internet stipend
• Growth opportunities within the organization